Formulation Technician II (12 hr days, A shift, 2-2-3)

Work Schedule 12 hr shift/days Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, Fluctuating Temps hot/cold, Laboratory Setting, Loud Noises (Equipment/Machinery), Office, Rapid flashing lights, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Strong Odors (chemical, lubricants, biological products etc.), Various outside weather conditions, Warehouse, Will work with hazardous/toxic materials, Working at heights Job Description As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. GROUP/DIVISION SUMMARY The Drug Product Division - South America (DPD-NA) is one of the five divisions that make up the Pharma Services Group. We are made up of approximately 4400 colleagues across six sites who specialize in taking sterile injectable and oral solid dose drug products from development to commercialization. POSITION SUMMARY The Formulation Tech I I s ets-up , operate s , and maintain s classified environments along with manufacturing equipment for filling pharmaceutical products. Shift hours are 6am-6pm on a 2-2-3 rotating schedule. Key Responsibilities: Ensures pharmaceutical products are manufactured in accordance to area SOPs and current cGMP. Verify and document production activities in batch records, logbooks and controlled forms. Complete assembly, disassembly and operation of area manufacturing equipment inside/outside the aseptic core: Filler Capper Freeze dryer (Lyo) loading/ Unloading Trayloader Vial Washe r SMEJA stopper processor Equipment and component sterilizers Filter integrity testers Piping changeover’s on the product delivery systems and CIP/SIP cycles (Filler/Stopper isolator) Assist with initial / subsequent validation of filling equipment and processes. General material handling Maintain/clean classified areas. This includes but is not limited to the aseptic core. Mechanical troubleshooting Clean pre and post use change parts and prep for sterilization. Participate in the On the Job (OJT) training program, area safety and Lean Manufacturing initiatives. Train new employees. Education: High school diploma or equivalent required. Experience: Required: Minimum of 1 year of work experience in a manufacturing, operations, production, lab setting or related field Preferred: Experience in a cGMP environment Knowledge, Skills, Abilities: Demonstrates the Thermo Fisher values (The Four I’s) – Integrity, Intensity, Innovation, and Involvement. General mechanical, electrical, pneumatic and hydraulic knowledge. Mechanical troubleshooting (manufacturing equipment preferred) Knowledge of Aseptic Cleaning and Aseptic gowning/technique Equipment change part cleaning and sterilization Component/commodity sterilization Knowledge of Good documentation practices Good written and oral communication , Attention to detail while maintaining a quality product Basic math skills Ability to use a computer Ability and desire to learn Stand for long periods of time <